Cleveland Clinic Diagnostic Patents Found Invalid

In Cleveland Clinic Foundation v. True Health Diagnostics, LLC., 1: 15-cv-2331 (N.D. Ohio 2016) (Available Here), the U.S. District Court for the Northern District of Ohio granted the defendant’s motion to dismiss finding three (3) of Cleveland Clinic Foundation’s (“CCF”) diagnostic patents invalid as being ineligible patent subject matter under the Patent Act, 35 U.S.C. § 101.

CCF’s patents involve a test that assesses a patient’s risk for cardiovascular disease (“CVD”). The test, measures myeloperoxidase enzyme or “MPO”, which indirectly measures inflammation of the blood vessels and is an early detector of many types of CVD.  The accused patent infringer – Defendant argued that three of the four CCF patents were invalid as being ineligible subject matter. According to Defendant, these patents are directed at a law of nature and contain no inventive step.

In the Supreme Court case of Alice Corp., the Supreme Court employed a two-part test for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible subjects or “subject matter”.   Alice Corp. Pty. Ltd. v. CLS Bank International, 134 S. Ct. 2347,  2355 (2014). First, a court must determine whether the claims at issue are directed at a patent ineligible concept. If the claims are so directed, the court must proceed to step two, which involves a determination as to whether the patent contains an inventive concept, which is described as an element or a combination of elements that is sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself. Id.

The District Court found that the CCF patents at issue were directed to a natural law, i.e. the correlation between MPO in the blood and the risk of CVD. The Court also found that the patents do not satisfy step two, namely, the patents do not contain an inventive concept. As for the “determining” step, this simply calls for determining MPO activity level by well-known methods. As for the “comparing” step, this is simply a mental step that compares the MPO level to a control. Moreover, the combination does not make the ineligible mental steps and natural law patent-eligible. The Court found the values are naturally occurring and their discovery does not render the patents eligible under §101 citing to Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015).

Further, the District Court found that the complaint does not state a claim for contributory infringement based solely on lab reports as a result of the service defendant provides. The Court also found that the complaint fails to sufficiently allege a claim for induced infringement, because the complaint contains no allegations even generally describing defendant’s alleged role in the infringement of CCF’s ‘260 patent or any manner in which defendant induces such infringement.

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